Introduction

Ground rules

Note

  • Safe space, and participation from all is encouraged.
  • Shared vision & common goal
  • Reach agreement between members of the group
  • Respectful dialogue between equals
  • ⏰ Short interventions only please!


What we won’t do

We will not make definitive decisions here and now:
Proposed structure and content will be defined by consensus after the WHO team have reviewed and addressed all comments.

We won’t discuss fine-grained decisions on variable coding or the structure of the data:
This is constrained by the WHO Global Clinical Platform.

We will not vote on specific variables:
The WHO team will use these discussions to support the trade-offs required to reach the lightweight end-product.

What next?

After the first meeting:

  • The WHO technical team will compile a new version of the Case Report Form (CRF) based on the discussions

    • Each discussion is happening twice to accommodate time zone differences

  • We may ask you to complete prioritisation surveys if there are difficult specific decisions

  • We will reconvene in a second meeting to iterate this discussion

  • Another meeting may be required to finalise and ensure consensus (not yet planned).

Final Goal


To develop a Case Report Form (CRF) to provide a harmonised, lightweight, and near real-time clinical surveillance system for dengue that enables facilities and national programmes to monitor clinical outcomes and support care quality improvement.

Intended use of the CRF

  • For patients admitted to a facility with clinical suspicion of dengue, with or without diagnostic confirmation, a lightweight CRF collected at exit from the clinical facility (or at one week, if sooner).



  • Aiming for 5 mins / patient average data capture time (≅ 25 variables) which capture:
    • baseline demographics;
    • parsimonious markers of severity (for example shock, platelet count);
    • process markers of clinical care which are amenable to quality improvement.



  • There is some flexibility in length, as some questions might prompt sub-questions i.e. would only be required in a smaller sub-cohort of patients.

The process: Steps Variable Selection

Note

  • Some variables have been identified as required by the WHO upon discussion with partners.
  • Some variables have proposed reorganisation / combination in order to reduce complexity.
  • The pre-meeting survey showed relative priorities for variables. It is used as a starting point for discussions!
    • Variables which were universally important or critical are provisionally marked for inclusion.
    • Variables which were important or critical for >40% of the respondents are marked for discussion.
    • Other variables are marked not for inclusion.

Qualitative criteria by which to judge variables

Represent a marker which is related to quality of care and is modifiable by an intervention:

Feasibility of capture:
- Available within 7 days to clinical staff.



Objectivity:
- Standardised definition and method of ascertainment.



Close to universally relevant:
- All settings.

Non-rare:
- Not designed for never events for example.



Discriminatory:

  • Likely to represent meaningful differences.

Variables marked as required

A priori:

  • Date of admission
  • Admission criteria
  • Age
  • Sex
  • Final diagnosis
  • Laboratory confirmation of aetiology
  • Outcome (at 7 days according to the protocol)
  • Date of outcome
  • Suspected or confirmed dengue at admission is inferred

Additional based on survey:

  • BP (diastolic/systolic)
  • Heart rate
  • Platelets
  • Hematocrit
  • Vaccinated for dengue
  • Shock

Variables discarded

Demographics

  • Race
  • Weight
  • Height
  • Current occupation or work environment
  • International travel prior to symptom onset
  • list country(ies) visited
  • Patient’s city of residence


Symptoms

  • Any ear, nose, eye or throat problem
  • Any vaginal problem
  • Cardiac abnormality
  • Chest pain
  • Diarrhoea
  • Fatigue or malaise
  • Headache
  • Joint/Muscle pain or aching
  • Loss of taste
  • Lymph node abnormality
  • Neurological abormality
  • Skin rash

Laboratory and Imagery:

  • APTT/INR/pt
  • Lymphocytes/Neutrophils
  • Other haematology results available
  • WCC total
  • Radiology results available
  • Xray Key findings


Diagnosis:

  • Arbovirus Type
  • Multiple Arbovirus Diagnoses


Treatments:

  • Paracetamol/acetaminophen
  • ECMO 

Variables with proposed reorganisation / combination

Variables marked for discussion

Variables Up for Discussion

Demographics/Baseline

  • Is the patient currently pregnant or was pregnant in the last 6 weeks?

Vitals

  • AVPU
  • Capillary refill ≥ 3 sec
  • GCS
  • Respiratory rate
  • SpO2
  • Temperature

Symptoms

  • Confusion or agitation
  • Fever
  • Seizures
  • Abdominal pain
  • Vomiting
  • Signs of ascites and pleural effusion
  • Tender abdomen

Comorbidities

  • Diabetes (type 1 or type 2)
  • Chronic heart disease (e.g., heart failure, coronary artery disease)
  • Chronic kidney disease
  • Chronic liver disease
  • Immunosuppressive condition or Immunosuppressive medication
  • Cancer diagnosis
  • Bleeding disorder or take anticoagulant/antiplatelet medication

Laboratory and Imagery

  • Hemoglobin
  • Creatinine
  • Blood count results available
  • DENV serotype

Complications

  • Acute Respiratory Distress Syndrome (ARDS)
  • Acute hepatitis
  • Hepatic encephalopathy (any grade)
  • Severe liver disease (new onset)
  • Ascites
  • Acute renal injury / Acute renal failure
  • Urine flow rate
  • Pleural effusion / Ascites
  • Hypertension
  • Cardiac arrest
  • Cardiac arrhythmia
  • Myocarditis / Pericarditis
  • Encephalitis / Meningitis
  • Focal neurological signs
  • Seizure
  • Sepsis
  • Severe bleeding
  • Severe organ impairment

Treatments

  • Blood transfusion
  • Platelets
  • Antivirals
  • Fluid drainage (Therapeutic ascitic/pleural tap included)
  • Highest level of respiratory support received
  • Renal replacement therapy (e.g., dialysis)
  • NSAIDs

Variables Not for Discussion

Vaccinations

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Vaccinated for dengue

Diagnosis

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Dengue virus infection
  • DENV PCR

Outcome

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Outcome at discharge
  • Date of discharge/transfer

Final Diagnosis

Important

Variables below are considered Core of the WHO Clinical data platform and are not to be discussed as part of this process.


  • Main diagnosis dengue?
  • Select Primary diagnosis if it is not Dengue
  • If no: What was the main diagnosis?
  • Final Clinical Inclusion Criteria
  • Type of Primary diagnosis

Thank you